Epilepsy Clinical Trial
Official title:
An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures
Verified date | December 2019 |
Source | Brain Sentinel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is an observational study of subjects receiving standard of care therapy, while admitted to Epilepsy Monitoring Unit, Department of Neurology, General Hospital Hietzing with Neurological Center Rosenhügel. Additional monitoring provided by the SPEAC System will be compared to the gold standard, vEEG. The SPEAC System is being evaluated while being used in adjunct to standard of care.
Status | Active, not recruiting |
Enrollment | 71 |
Est. completion date | February 1, 2020 |
Est. primary completion date | February 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: 1. Subject has a suspected history of PNES with upper extremity motor involvement or epileptic seizures with upper extremity motor involvement. 2. Is being admitted to a hospital for routine vEEG monitoring related to seizures. 3. Male or female between the ages of 18-99. 4. If female and of childbearing potential, has a negative pregnancy test. 5. Can understand and sign written informed consent prior to the performance of any study assessments. 6. Subject must be competent to follow all study procedures. Exclusion Criteria: 1.Intracranial EEG electrodes are being used. |
Country | Name | City | State |
---|---|---|---|
Austria | Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel | Wien |
Lead Sponsor | Collaborator |
---|---|
Brain Sentinel |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3 independent physicians' abilities to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using vEEG, using a majority rules approach (2 out of 3) | The primary endpoint is to test a physician's ability to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using vEEG review. PNES and epileptic seizures will initially be identified, described, and documented following routine clinical care (vEEG). | 5 days | |
Primary | 3 independent physicians' abilities to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using sEMG, using a majority rules approach (2 out of 3) | The primary endpoint is to test a physician's ability to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using sEMG recorded by the SPEAC System. PNES and epileptic seizures will initially be identified, described, and documented following routine clinical care (vEEG). The sEMG record will be evaluated to identify PNES, displaying upper extremity motor components, and epileptic seizures, displaying upper extremity (UE) motor components. It is anticipated that > 70% of PNES with UE motor involvement identified by vEEG will be identified by sEMG recordings as well. | 5 days | |
Secondary | To evaluate the System's ability to detect GTC seizures, as compared to vEEG monitoring | It is anticipated that >70% of GTC seizures identified by vEEG will be identified by the SPEAC System's automated alarms as well. | 5 days |
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